Home NDC 50090-2345 Methotrexate
Product NDC 50090-2345
11-digit product format 500902345
Labeler code 50090
Product ID 50090-2345_279705af-fac8-4afa-bd44-0980ef359a7d
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Methotrexate
Dosage form TABLET
Route ORAL
Labeler A-S Medication Solutions
Application ANDA081099
Marketing category ANDA
Marketing start 1990-11-01
Marketing end 0000-00-00
Substance METHOTREXATE SODIUM
Active strength 3 mg/1
Pharmacologic classes Folate Analog Metabolic Inhibitor [EPC],Folic Acid Metabolism Inhibitors [MoA]
NDC exclude flag No
Listing certified through 2019-12-31
Current FDA listing Historical FDA.report record Observed NDC auxiliary status history# This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
Historic NDC status page 1 of 1 · 54 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Package NDC Code Status Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 excluded product product I Inactivated by FDA d630ba8d3edf…732f749b63fb…2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 50090-2345-9 I Inactivated by FDA d630ba8d3edf…732f749b63fb…2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 50090-2345-4 D Discontinued by firm d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 excluded product product I Inactivated by FDA f5e01cc5f278…a2eaf40c39c3…2025-08-27 00:01 UTC · source 2025-08-26 excluded package package 50090-2345-9 I Inactivated by FDA f5e01cc5f278…a2eaf40c39c3…2025-08-27 00:01 UTC · source 2025-08-26 excluded package package 50090-2345-4 D Discontinued by firm f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 excluded product product I Inactivated by FDA 2ef7874e63bc…57b86245f4fa…2025-04-01 02:39 UTC · source 2025-03-31 excluded package package 50090-2345-9 I Inactivated by FDA 2ef7874e63bc…57b86245f4fa…2025-04-01 02:39 UTC · source 2025-03-31 excluded package package 50090-2345-4 D Discontinued by firm 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 excluded product product I Inactivated by FDA a1b67e2a42f9…c4cf2c586c0d…2025-03-28 20:22 UTC · source 2025-03-28 excluded package package 50090-2345-9 I Inactivated by FDA a1b67e2a42f9…c4cf2c586c0d…2025-03-28 20:22 UTC · source 2025-03-28 excluded package package 50090-2345-4 D Discontinued by firm a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 excluded product product I Inactivated by FDA cfe11265f3b6…090c488252e2…2025-03-22 03:12 UTC · source 2025-03-21 excluded package package 50090-2345-9 I Inactivated by FDA cfe11265f3b6…090c488252e2…2025-03-22 03:12 UTC · source 2025-03-21 excluded package package 50090-2345-4 D Discontinued by firm cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 excluded product product I Inactivated by FDA cdf11ea48f46…ba0047e9e063…2025-03-10 12:48 UTC · source 2025-03-10 excluded package package 50090-2345-9 I Inactivated by FDA cdf11ea48f46…ba0047e9e063…2025-03-10 12:48 UTC · source 2025-03-10 excluded package package 50090-2345-4 D Discontinued by firm cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 excluded product product I Inactivated by FDA 302b2466d912…e7b80fea0513…2025-02-02 03:52 UTC · source 2025-01-31 excluded package package 50090-2345-9 I Inactivated by FDA 302b2466d912…e7b80fea0513…2025-02-02 03:52 UTC · source 2025-01-31 excluded package package 50090-2345-4 D Discontinued by firm 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 excluded product product I Inactivated by FDA ed331223b511…672a5bd82f5f…2025-01-20 13:05 UTC · source 2025-01-20 excluded package package 50090-2345-9 I Inactivated by FDA ed331223b511…672a5bd82f5f…2025-01-20 13:05 UTC · source 2025-01-20 excluded package package 50090-2345-4 D Discontinued by firm ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 excluded product product I Inactivated by FDA 0efc9e666f02…f202fb6c5f17…2025-01-11 03:41 UTC · source 2025-01-10 excluded package package 50090-2345-9 I Inactivated by FDA 0efc9e666f02…f202fb6c5f17…2025-01-11 03:41 UTC · source 2025-01-10 excluded package package 50090-2345-4 D Discontinued by firm 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 excluded product product I Inactivated by FDA ad56d346431e…cc804d4bbf1e…2024-11-09 02:27 UTC · source 2024-11-08 excluded package package 50090-2345-9 I Inactivated by FDA ad56d346431e…cc804d4bbf1e…2024-11-09 02:27 UTC · source 2024-11-08 excluded package package 50090-2345-4 D Discontinued by firm ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 excluded product product I Inactivated by FDA 367a005e9d99…383a685ebd0f…2024-10-04 04:10 UTC · source 2024-10-03 excluded package package 50090-2345-9 I Inactivated by FDA 367a005e9d99…383a685ebd0f…2024-10-04 04:10 UTC · source 2024-10-03 excluded package package 50090-2345-4 D Discontinued by firm 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 excluded product product I Inactivated by FDA 557ba5c1ecfa…9c80585c8c6e…2024-07-10 04:00 UTC · source 2024-07-09 excluded package package 50090-2345-9 I Inactivated by FDA 557ba5c1ecfa…9c80585c8c6e…2024-07-10 04:00 UTC · source 2024-07-09 excluded package package 50090-2345-4 D Discontinued by firm 557ba5c1ecfa…9c80585c8c6e…2024-05-28 21:12 UTC · source 2024-05-28 excluded product product I Inactivated by FDA 8af77b9d5b6f…d9bbb34c5368…2024-05-28 21:12 UTC · source 2024-05-28 excluded package package 50090-2345-9 I Inactivated by FDA 8af77b9d5b6f…d9bbb34c5368…2024-05-15 03:39 UTC · source 2024-05-14 excluded product product I Inactivated by FDA 834df4deac94…adcc014656a3…2024-05-15 03:39 UTC · source 2024-05-14 excluded package package 50090-2345-9 I Inactivated by FDA 834df4deac94…adcc014656a3…2024-03-11 06:39 UTC · source 2024-03-08 excluded product product I Inactivated by FDA 1332a3947898…d4bfe170f9cd…2024-03-11 06:39 UTC · source 2024-03-08 excluded package package 50090-2345-9 I Inactivated by FDA 1332a3947898…d4bfe170f9cd…2022-08-30 03:57 UTC · source 2022-08-29 excluded product product I Inactivated by FDA fb8cb913e6d1…eb8c232b6be0…2022-08-30 03:57 UTC · source 2022-08-29 excluded package package 50090-2345-9 I Inactivated by FDA fb8cb913e6d1…eb8c232b6be0…2022-04-09 23:13 UTC · source 2022-04-08 excluded product product I Inactivated by FDA 86f5da6cb304…a595104c45d7…2022-04-09 23:13 UTC · source 2022-04-08 excluded package package 50090-2345-9 I Inactivated by FDA 86f5da6cb304…a595104c45d7…2022-04-04 05:40 UTC · source 2022-04-01 excluded product product I Inactivated by FDA bd6a592717d7…303034d00443…2022-04-04 05:40 UTC · source 2022-04-01 excluded package package 50090-2345-9 I Inactivated by FDA bd6a592717d7…303034d00443…2021-12-27 23:28 UTC · source 2021-12-27 excluded product product I Inactivated by FDA 8dfbde2a14a4…c9ff85d89658…2021-12-27 23:28 UTC · source 2021-12-27 excluded package package 50090-2345-9 I Inactivated by FDA 8dfbde2a14a4…c9ff85d89658…2020-12-18 03:04 UTC · source 2020-12-17 excluded product product I Inactivated by FDA e2bbac7714bc…27bdfed8d636…2020-12-18 03:04 UTC · source 2020-12-17 excluded package package 50090-2345-9 I Inactivated by FDA e2bbac7714bc…27bdfed8d636…2020-06-10 20:45 UTC · source 2020-06-10 excluded product product I Inactivated by FDA 9bebd1f3094a…5416666fcb17…2020-06-10 20:45 UTC · source 2020-06-10 excluded package package 50090-2345-9 I Inactivated by FDA 9bebd1f3094a…5416666fcb17…
Source provenance: Browse the complete Orange Book source catalog · source snapshot 42 .
Orange Book products# Current product rows page 1 of 1 · 1 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A081099-001 METHOTREXATE SODIUM METHOTREXATE SODIUM EQ 2.5MG BASE TABLET / ORAL AB 1990-10-15
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A081099-001 AB
Observed Orange Book product history# Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.
Product history page 1 of 2 · 42 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-08-18 06:07:40 2026-07 A081099-001 METHOTREXATE SODIUM EQ 2.5MG BASE TABLET / ORAL AB 1990-10-15 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A081099-001 METHOTREXATE SODIUM EQ 2.5MG BASE TABLET / ORAL AB 1990-10-15 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A081099-001 METHOTREXATE SODIUM EQ 2.5MG BASE TABLET / ORAL AB 1990-10-15 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A081099-001 METHOTREXATE SODIUM EQ 2.5MG BASE TABLET / ORAL AB 1990-10-15 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A081099-001 METHOTREXATE SODIUM EQ 2.5MG BASE TABLET / ORAL AB 1990-10-15 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A081099-001 METHOTREXATE SODIUM EQ 2.5MG BASE TABLET / ORAL AB 1990-10-15 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A081099-001 METHOTREXATE SODIUM EQ 2.5MG BASE TABLET / ORAL AB 1990-10-15 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A081099-001 METHOTREXATE SODIUM EQ 2.5MG BASE TABLET / ORAL AB 1990-10-15 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A081099-001 METHOTREXATE SODIUM EQ 2.5MG BASE TABLET / ORAL AB 1990-10-15 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A081099-001 METHOTREXATE SODIUM EQ 2.5MG BASE TABLET / ORAL AB 1990-10-15 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A081099-001 METHOTREXATE SODIUM EQ 2.5MG BASE TABLET / ORAL AB 1990-10-15 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A081099-001 METHOTREXATE SODIUM EQ 2.5MG BASE TABLET / ORAL AB 1990-10-15 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A081099-001 METHOTREXATE SODIUM EQ 2.5MG BASE TABLET / ORAL AB 1990-10-15 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A081099-001 METHOTREXATE SODIUM EQ 2.5MG BASE TABLET / ORAL AB 1990-10-15 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A081099-001 METHOTREXATE SODIUM EQ 2.5MG BASE TABLET / ORAL AB 1990-10-15 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A081099-001 METHOTREXATE SODIUM EQ 2.5MG BASE TABLET / ORAL AB 1990-10-15 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A081099-001 METHOTREXATE SODIUM EQ 2.5MG BASE TABLET / ORAL AB 1990-10-15 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A081099-001 METHOTREXATE SODIUM EQ 2.5MG BASE TABLET / ORAL AB 1990-10-15 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A081099-001 METHOTREXATE SODIUM EQ 2.5MG BASE TABLET / ORAL AB 1990-10-15 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A081099-001 METHOTREXATE SODIUM EQ 2.5MG BASE TABLET / ORAL AB 1990-10-15 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A081099-001 METHOTREXATE SODIUM EQ 2.5MG BASE TABLET / ORAL AB 1990-10-15 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A081099-001 METHOTREXATE SODIUM EQ 2.5MG BASE TABLET / ORAL AB 1990-10-15 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A081099-001 METHOTREXATE SODIUM EQ 2.5MG BASE TABLET / ORAL AB 1990-10-15 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A081099-001 METHOTREXATE SODIUM EQ 2.5MG BASE TABLET / ORAL AB 1990-10-15 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A081099-001 METHOTREXATE SODIUM EQ 2.5MG BASE TABLET / ORAL AB 1990-10-15 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A081099-001 METHOTREXATE SODIUM EQ 2.5MG BASE TABLET / ORAL AB 1990-10-15 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A081099-001 METHOTREXATE SODIUM EQ 2.5MG BASE TABLET / ORAL AB 1990-10-15 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A081099-001 METHOTREXATE SODIUM EQ 2.5MG BASE TABLET / ORAL AB 1990-10-15 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A081099-001 METHOTREXATE SODIUM EQ 2.5MG BASE TABLET / ORAL AB 1990-10-15 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A081099-001 METHOTREXATE SODIUM EQ 2.5MG BASE TABLET / ORAL AB 1990-10-15 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A081099-001 METHOTREXATE SODIUM EQ 2.5MG BASE TABLET / ORAL AB 1990-10-15 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A081099-001 METHOTREXATE SODIUM EQ 2.5MG BASE TABLET / ORAL AB 1990-10-15 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A081099-001 METHOTREXATE SODIUM EQ 2.5MG BASE TABLET / ORAL AB 1990-10-15 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A081099-001 METHOTREXATE SODIUM EQ 2.5MG BASE TABLET / ORAL AB 1990-10-15 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A081099-001 METHOTREXATE SODIUM EQ 2.5MG BASE TABLET / ORAL AB 1990-10-15 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A081099-001 METHOTREXATE SODIUM EQ 2.5MG BASE TABLET / ORAL AB 1990-10-15 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A081099-001 METHOTREXATE SODIUM EQ 2.5MG BASE TABLET / ORAL AB 1990-10-15 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A081099-001 METHOTREXATE SODIUM EQ 2.5MG BASE TABLET / ORAL AB 1990-10-15 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A081099-001 METHOTREXATE SODIUM EQ 2.5MG BASE TABLET / ORAL AB 1990-10-15 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A081099-001 METHOTREXATE SODIUM EQ 2.5MG BASE TABLET / ORAL AB 1990-10-15 e64feba35796…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 42 observed states.
DailyMed Product Concepts# FDA-Initiated Inactive NDC Indexing# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 50090-2345-4 Methotrexate 12 in 1 BOTTLE TABLET 12 7 50090-2345-9 Methotrexate 36 in 1 BOTTLE TABLET 36 7
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 50090-2345 METHOTREXATE TABLET [A-S MEDICATION SOLUTIONS] 7 Legacy NDC, 2 package rows 20190225_02862eb3-5508-4ea9-99fb-262551b6beeb.zip
openFDA label cross-check# OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
Matched openFDA labels page 1 of 1 · 4 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Methotrexate METHOTREXATE AvKARE 757d6cef-6696-7a1c-8074-01258aaa8bdd 2026-07-23 Boxed warning, Adverse reactions Exact identifier application applno (ANDA): 081099 application number: ANDA081099 Methotrexate METHOTREXATE Teva Pharmaceuticals USA, Inc. 9b34b1d8-d125-41a2-9f6f-3fab67b573bd 2026-06-04 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 081099 application number: ANDA081099 Methotrexate METHOTREXATE A-S Medication Solutions 22e10810-16fb-4c84-bccf-972405b77ef8 2026-02-04 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 081099 application number: ANDA081099 Methotrexate METHOTREXATE Bryant Ranch Prepack e6611304-4622-4b2e-9b94-57fbad023ae2 2024-10-01 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 081099 application number: ANDA081099
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Status 50090-2345-4 50090234504 12 in 1 BOTTLE Historical 50090-2345-9 50090234509 36 in 1 BOTTLE Historical